1. Field of the Invention
The present invention generally relates to containers formed with separate compartments for storage of separate substances with a removable partition to permit internal mixing of said substances to form a mixed fluid dispensable from the container.
2. Discussion of Related Art
Various designs have been utilized in the syringe and pharmaceutical container arts to provide for the mixing of two substances. These designs have frequently involved systems wherein one of the two substances is a solid drug (e.g., a drug powder) and the other of the two substances is a solvent suitable for reconstituting the drug powder to form a solution. Many of these container designs are provided with a rubber plug or other type of closure which allows the mixture of substances to be drawn up into a hypodermic syringe. Reference is made to the following U.S. patents for further details and background regarding such syringes and containers: U.S. Pat. Nos. 2,494,456; 2,568,029; 2,653,610; 2,900,100; 3,464,414; 3,539,794; 3,595,439; 3,684,136; 3,715,189; 3,720,523; 3,731,853; 3,739,947; 3,741,383; 3,756,390; 3,785,481; 3,809,225; 4,102,451; and 4,193,698. The container of the present invention is specially adapted for the mixing and dispensing of sterile irrigating solutions.
Sterile irrigating solutions are often used during intraocular surgical procedures requiring a relatively long perfusion time. One type of irrigating solution which can be dispensed with the present invention is BSS PLUS.RTM., which is a solution consisting of two separate parts which are mixed aseptically immediately prior to use. BSS PLUS.RTM. is disclosed and claimed in commonly assigned U.S. patent application Ser. No. 582,564, the entire contents of which are incorporated herein by reference.
As presently used, BSS PLUS.RTM. Parts I and II are stored in separate containers. Immediately prior to use, it is necessary to clean and disinfect rubber stoppers on both containers by using sterile alcohol wipes. Thereupon, the contents of the Part II vial are transferred to the Part I bottle utilizing a vacuum transfer device. An alternate method of solution transfer may be accomplished by using a syringe to remove the Part II solution from the vial and transferring it to the Part I container through the target area of the rubber stopper. An excess volume of Part II is provided in each vial. The container is then gently agitated to mix the solution. A sterile dispensing plastic spike is then inserted into the container to dispense the fluid so that intraocular irrigation can begin.
Storage of Parts I and II of BSS PLUS.RTM. in separate vials followed by reconstitution in the manner described above is time consuming and requires the use of two hands. Further, strict aseptic procedures similar to those used for intravenous products must be followed during the reconstitution of BSS PLUS.RTM..
It is accordingly an object of the present invention to provide a dual compartment container for aseptic, separate storage and internal mixing of two substances to form a mixed fluid dispensable from the container at time of use.
Another object of the invention is to provide a container wherein mixing of the separate substances is convenient and does not require the use of strict aseptic procedures at the time of mixing.
Still another object is to provide a two-part container which ensures that both substances are thoroughly mixed prior to use and completely dispensed from the container by forming the container with a squeezable wall.
A still further object is to provide a dual compartment disposable syringe package for separate storage of Parts I and II of BSS PLUS.RTM. and Internal mixing of Parts I and II within the container to form the reconstituted product.